Novel Skin Barrier Product Versus Petrolatum for Skin Barrier Dysfunction
NCT ID: NCT07183423
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
26 participants
INTERVENTIONAL
2025-08-31
2025-10-31
Brief Summary
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Does the novel barrier topical product improve skin hydration, skin sebum, redness, and pigmentation? Does it improve subjective dryness and itch? Researchers will compare the novel barrier topical product to petrolatum (a gold standard occlusive barrier repair agent) to see how they are comparable in treating skin barrier dysfunction.
Participants will:
Apply the novel barrier topical product or petrolatum twice a day for 28 days Visit the clinic once a week for checkups and tests Keep a diary of their application of the assigned product
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Detailed Description
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The main questions it aims to answer are:
Primary Objective: In a pilot study, to compare the preliminary effectiveness of the test product (containing ceramides, cholesterol, coconut oil and monolaurin) versus petrolatum in improving skin barrier function, as measured by transepidermal water loss (using a Tewameter), skin hydration (using a Corneometer), skin lipids (using a Sebumeter) as well as skin erythema and pigmentation (using a Mexameter) over a four-week period.
Secondary Objectives:
To assess improvement in subjective symptoms (dryness, pruritus). To assess patient-reported outcomes, including comfort, ease of application, and overall satisfaction.
To monitor and compare any adverse events or skin reactions associated with both treatments.
Researchers will compare versus petrolatum to see if effects are comparable. Participants will upon enrollment to the study, be asked to accomplish the Personal Information Sheet and Patient Satisfaction Questionnaire. They will be taught how to mark the Visual Analogue Scale according to the degree of dryness and itch felt. They will accomplish this at Baseline, weeks 1, 2 and 4.
Non-invasive measurements will be done of: skin hydration (using Tewameter and Corneometer), skin sebum (using Sebumeter) and skin redness/pigmentation (using Mexameter) at baseline, weeks 1, 2, and 4. Pictures will also be taken of the test area at each visit.
All participants will be given a 1 or 3-week supply of either the test medication or the placebo in identical jars, color, and smell to maintain blinding. Refills will be given at each follow-up. Written instructions on how to use them will also be provided. The product will be applied twice daily on the right forearm for 28 days. The amount applied will be ⅛ teaspoon per application, with a plastic measuring spoon given for their use. They will be instructed not to apply the product to any other location. They will also be advised on the possible adverse effects and will be instructed to contact the investigator in case an adverse reaction happens. They will then be instructed to follow up after 1, 2, and 4 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Right Arm: Applying Test Product
Novel barrier repair topical product
Novel barrier product (containing ceramide, virgin coconut oil, cholesterol)
Left Arm: Applying no topicals
No interventions assigned to this group
Petrolatum: Right Arm: Applying Petrolatum
Petrolatum
Petrolatum application
Interventions
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Novel barrier repair topical product
Novel barrier product (containing ceramide, virgin coconut oil, cholesterol)
Petrolatum
Petrolatum application
Eligibility Criteria
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Inclusion Criteria
* Mild to moderate atopic dermatitis, defined as SCORAD ≤ 50, and/or not currently requiring topical corticosteroids or immunomodulators.
* Mild to moderate chronic plaque psoriasis, defined as total body surface area (BSA) involved: ≤3% to 10%.
* Contact dermatitis
* Seasonal xerosis or clinically evident skin dryness
* Symmetrical or bilateral test areas available (volar forearm)
* Willing and able to provide informed consent and adhere to study procedures
* Severe atopic dermatitis or psoriasis requiring systemic or high-potency topical treatment
* Use of corticosteroids, calcineurin inhibitors, biologics, or phototherapy within 2 weeks
* Open wounds or evidence of secondary infection at test sites
* Pregnant or breastfeeding women
* Multiple nevi, tattoos, dense body hair in the test areas
* Debilitated or immunocompromised subjects
* Known or suspected hypersensitivity to the interventional product (or its ingredients) or petrolatum
* Refusal or failure to comply with the schedule of visits at the test site.
18 Years
ALL
No
Sponsors
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Makati Medical Center
OTHER
Responsible Party
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Dr. Vermen Verallo-Rowell
Past Chairman of Dermatology, Current Active Consultant
Principal Investigators
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Vermen M Verallo Rowell, MD
Role: PRINCIPAL_INVESTIGATOR
VMV Skin Research Center & Clinics
Locations
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VMV Skin Research Center & Clinics
Makati City, National Capital Region, Philippines
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MMCIRB2025-06-91
Identifier Type: -
Identifier Source: org_study_id
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